Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in 6-min walk distance for each prosthetic foot type |
The 6-minute walk test measures the distance an individual can walk in 6 minutes without help or encouragement. |
Once per week, at Week 1, Week 2, and Week 3 after enrollment |
|
| Primary |
Change in TUG times for each prosthetic foot type |
The TUG measures the time taken by an individual to stand up from a standard arm chair, walk a distance of 10 feet, turn, walk back to the chair, and sit down. |
Once per week, at Week 1, Week 2, and Week 3 after enrollment |
|
| Primary |
Change in 4SST times for each prosthetic foot type |
The four-square step test is a higher order complex task assessing dynamic balance. |
Once per week, at Week 1, Week 2, and Week 3 after enrollment |
|
| Primary |
Change in AmpPRO for each prosthetic foot type |
The AmpPro is a 21-item instrument designed to measure basic prosthetic mobility of individuals with lower extremity amputation. |
Once per week, at Week 1, Week 2, and Week 3 after enrollment |
|
| Primary |
Change in Stair Assessment Index (SAI) for each prosthetic foot type |
The SAI is a rated qualitative scale on how an individual with lower limb amputation negotiates up and down a staircase. |
Once per week, at Week 1, Week 2, and Week 3 after enrollment |
|
| Primary |
Change in Hill Assessment Index (HAI) for each prosthetic foot type |
The HAI is a rated qualitative scale on how an individual with lower limb amputation negotiates up and down a ramp. |
Once per week, at Week 1, Week 2, and Week 3 after enrollment |
|
| Primary |
Change in Gait Evaluation for each prosthetic foot type |
Biomechanical evaluation of gait. |
Once per week, at Week 1, Week 2, and Week 3 after enrollment |
|
| Secondary |
Change in Prosthetic Evaluation Questionnaire (PEQ) score for each prosthetic foot type |
The PEQ is a self-report Visual Analog Scale questionnaires for persons with lower limb amputations who use a prosthesis. It consists of 9 validated subscales. They are used to evaluate the prosthesis and life with the prosthesis. Most questions in the PEQ use a visual analog scale format. Each visual analog scale is scored as a continuous numerical variable measured as the distance in millimeters from the left endpoint of the line to the point at which the respondent's mark crosses the line. Each line is 100 mm long and is always measured from the left (0-100). The questions are all worded so that a higher number (toward the right) will correspond with a more positive response. Subscale scores are calculated by computing the average (arithmetic mean) of all the questions which make up that particular scale. Only subscales are calculated. A total combined score is not calculated. |
Once per week, at Week 1, Week 2, and Week 3 after enrollment |
|
| Secondary |
Change in Short Form (SF)-12 for each prosthetic foot type |
The SF-12 is a questionnaire used to measure the relationship between physical and mental health functioning and the social determinants of health. It is a self-reported questionnaire, on a rating scale, called a Likert Scale. The participant taking this questionnaire will check one response box per question. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Age-specific mean difference score (difference score) is calculated and is the amount by which a person's score differs from their age group's mean score. By looking at difference scores, it is clear whether a person is more or less healthy than other persons in his or her comparison group. |
Once per week, at Week 1, Week 2, and Week 3 after enrollment |
|
| Secondary |
Change in OPUS for each prosthetic foot type |
OPUS is a set of self-report instruments that assess functional status, quality of life, and satisfaction with devices and services that can be used in an orthotics and prosthetics clinic. The OPUS Health Quality of Life Score is the sum of the scores for the 23 items (0 - 92). The OPUS lower extremity total score is the sum of the scores for the 20 items (0 - 80). OPUS Satisfaction With Device Score is the sum of the scores for items 1-11 (11 - 55). Satisfaction With Services Score is the sum of the scores for items 12-21 (10 - 50). A higher score indicates a better outcome for all measures. |
Once per week, at Week 1, Week 2, and Week 3 after enrollment |
|
| Secondary |
Final Visit Guided Interview |
Final Visit questionnaire to evaluate subjective preferences. This is a free response questionnaire, in which the participant can answer in open-ended format. |
Administered one time at Final Visit, which will occur 7 weeks after enrollment. |
|
| Secondary |
Change in responses to Prosthetic Evaluation Questionnaire-Addendum (PEQ-A) for each prosthetic foot type |
The PEQ-A is a free response 2-question questionnaire, in which the participant is asked whether and how many times they had experienced a fall or near-fall in the previous week using the particular prosthetic foot. |
Once per week, at Week 1, Week 2, and Week 3 after enrollment |
|
